Trial · NCT03110029
Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish
NCT03110029, Phase 4, Completed, University of Alabama at Birmingham; results first posted 2019-03-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish. Trials, record NCT03110029. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03110029
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish
- NCT number
- NCT03110029
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 13 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Onychomycosis of Toenail
- Interventions
- Efinaconazole 10% Topical Application Solution [JUBLIA], Application of Nail Polish
- First posted
- 2017-04-12
- Last updated
- 2019-06-27
- Results first posted
- 2019-03-20
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Nail Polish Disruption Using the Likert Scale | 52 weeks | Patients will answer the following question: Which will be answered using a Likert scale where 0 represents no alteration in polish and 10 represents complete destruction of the polish: Is the quality of your polish diminished with use of Jublia? |
| Secondary | Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI) | 52 week | Using 3rd party blinding, DLSO was assessed at baseline and at every subsequent visit using the onychomycosis severity index (OSI), measuring percent of the target nail involved, and grading the infection from mild to moderate to severe. The range for OSI is 0-20 with 20 indicating severe nails disease. Nail growth was measured at each visit. Fungal testing was done at screening, 3 months, 7 months, end of treatment (48 weeks), and end of study (52 weeks). Clinical and mycologic cure was evaluated at week 52. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Nail Polish Disruption Using the Likert Scale | 52 weeks | Only participants who completed the trial were included in results. Two participants withdrew due to personal scheduling conflicts. | percentage of nail polish disruption | MEAN |
| SECONDARY | Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI) | 52 week | We did not include results from the two participants who withdrew from the study due to personal scheduling conflicts. Results for only 11 subjects who completed the study are represented in the number of participants analyzed. | percentage change target nail | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Nail Polish Disruption Using the Likert Scale | Wearing Toenail Polish | 0.6 | Full Range 0 to 100 | percentage of nail polish disruption | |
| Percentage of Nail Polish Disruption Using the Likert Scale | Abstain From Wearing Toenail Polish | 0 | Full Range 0 to 100 | percentage of nail polish disruption | |
| Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI) | Wearing Toenail Polish | 0.56 | Full Range 0 to 100 | percentage change target nail | |
| Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI) | Abstain From Wearing Toenail Polish | 0.54 | Full Range 0 to 100 | percentage change target nail |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Study Group (Frequently Wears Toenail Polish) | 7 | |
| Overall Study | STARTED | Control Group (no Toenail Polish) | 6 | |
| Overall Study | COMPLETED | Study Group (Frequently Wears Toenail Polish) | 6 | |
| Overall Study | COMPLETED | Control Group (no Toenail Polish) | 5 | |
| Overall Study | NOT COMPLETED | Study Group (Frequently Wears Toenail Polish) | 1 | |
| Overall Study | NOT COMPLETED | Control Group (no Toenail Polish) | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Efinaconazole 10% and Nail Polish | 0 | 7 |
| Total, all-cause mortality | Efinaconazole 10% Without Nail Polish | 0 | 6 |
| Total, other adverse events | Efinaconazole 10% and Nail Polish | 0 | 7 |
| Total, other adverse events | Efinaconazole 10% Without Nail Polish | 0 | 6 |
| Total, serious adverse events | Efinaconazole 10% and Nail Polish | 0 | 7 |
| Total, serious adverse events | Efinaconazole 10% Without Nail Polish | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Efinaconazole 10% and Nail Polish vs Efinaconazole 10% Without Nail Polish: deaths from any cause | Trial comparisons |
| Efinaconazole 10% and Nail Polish vs Efinaconazole 10% Without Nail Polish: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03110029
GET https://conductscience.org/api/trials/v1/NCT03110029/registered